Sometimes an unexpected result can occur in any research effort. In a large team effort this unexpected result may be due to factors beyond the expertise of the team. Applying outside expert analysis can clarify the issue.

Case Study

The Problem

Black spots appeared at the end of extensive processing, during the development phase of a medical device component. The client needed to learn the nature and origin of the spots to determine how to prevent them.

The Approach

The first step was to identify the black spots using a combination of micro- Fourier Transform Infrared Spectroscopy (µFTIR) and Advanced Scanning Electron Microscopy (ASEM) with Energy Dispersive X-ray Spectroscopy (EDS). These tools determined that the black specks were associated with higher levels of an organic material on the surface of the sample. The problem was that the contaminant that was found should not have been on the surface in the first place, and there was no visible evidence of contamination until the end of an extensive manufacturing process.

Working hand-in-hand with the client’s process engineering team, we designed an experiment to map the surface of the incoming raw materials. Then, maintaining the analysis coordinate system we generated, we returned the sample to the client for the next processing step, after which we again received the material for analysis. This back-and-forth protocol continued through each step in the manufacturing process. The goal was to understand the material distribution, record any changes through the processing steps, and not further contaminate the sample.

The Results

Using this iterative sampling technique, and coupling the client’s experience with his material and Analytical Answers’ experience in analysis and problem solving, we found that the contaminant entered the manufacturing process in the first step. The mechanical treatment of the sample spread it unevenly over the surface producing local “hot spots.” It was not until the final processing step however, that the contaminant became visible as black spots.